Entecavir Aurovitas

Package Leaflet: Information for the User

Entecavir Aurovitas, 0.5 mg, Film-Coated Tablets

Entecavir Aurovitas, 1 mg, Film-Coated Tablets

Entecavir

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Entecavir Aurovitas and what is it used for
• 2. Important information before taking Entecavir Aurovitas
• 3. How to take Entecavir Aurovitas
• 4. Possible side effects
• 5. How to store Entecavir Aurovitas
• 6. Contents of the pack and other information

1. What is Entecavir Aurovitas and what is it used for

Entecavir Aurovitas in the form of tablets is an antiviral medicine used in adults to treat chronic (long-term) hepatitis B virus (HBV) infection.

(HBV).Entecavir Aurovitas can be used in patients with damaged liver, but still functioning properly (with compensated liver function) and in patients whose liver is not functioning properly (with decompensated liver function).

Entecavir Aurovitas in the form of tablets is also used to treat chronic (long-term) HBV infection in children and adolescents from 2 years to less than 18 years of age.

Entecavir Aurovitas can be used in children whose liver is damaged, but still functioning properly (with compensated liver function).
Hepatitis B virus infection can lead to liver damage. Entecavir Aurovitas reduces the amount of virus in the body and improves liver function.

2. Important information before taking Entecavir Aurovitas

When not to take Entecavir Aurovitas

If you are allergic (hypersensitive)to entecavir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Entecavir Aurovitas, discuss this with your doctor or pharmacist.

• If you have ever had kidney disease, tell your doctor. This is important because Entecavir Aurovitas is removed from the body by the kidneys and may need to have the dose reduced or the dosing interval changed.
• Do not stop taking Entecavir Aurovitas without consulting your doctor, as this may affect the course of hepatitis. After stopping Entecavir Aurovitas, your doctor will monitor your condition and perform blood tests for several months.
• Discuss with your doctor whether your liver is working properly, and if not, what the potential impact on your treatment with Entecavir Aurovitas may be.
• If you are also infected with HIV (human immunodeficiency virus), tell your doctor. You should not take Entecavir Aurovitas to treat hepatitis B virus infection if you are not taking medicines for HIV, as this may reduce the future effectiveness of HIV treatment. Entecavir Aurovitas does not treat HIV infection.
• Taking Entecavir Aurovitas does not prevent the infection of other people with hepatitis B virus (HBV)through sexual contact or bodily fluids (including infected blood). Therefore, it is important to take appropriate precautions to prevent the spread of HBV to other people. A vaccine is available to protect people at risk of HBV infection.
• Entecavir Aurovitas belongs to a group of medicines that can cause lactic acidosis (excess of lactic acid in the blood)and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. This is a rare but serious side effect, sometimes fatal. Lactic acidosis occurs more often in women, especially those who are significantly overweight. While taking Entecavir Aurovitas, your doctor will regularly monitor your condition.
• If you have been previously treated for chronic hepatitis B, tell your doctor.

Children and adolescents

Entecavir Aurovitas should not be used in children under 2 years of age or weighing less than 10 kg.

Entecavir Aurovitas and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

Taking Entecavir Aurovitas with food and drink

In most cases, Entecavir Aurovitas can be taken with or without food. However, if you have previously taken medicines containing lamivudine as the active substance, consider the following recommendations. If the treatment has been changed to Entecavir Aurovitas due to lamivudine treatment failure, take Entecavir Aurovitas once daily on an empty stomach. If liver disease is very advanced, your doctor may also recommend taking Entecavir Aurovitas on an empty stomach. This means taking the medicine at least 2 hours after a meal and at least 2 hours before the next meal.

Entecavir Aurovitas 0.5 mg:

Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Aurovitas regardless of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or planning to have a baby, ask your doctor for advice. So far, it has not been shown that taking Entecavir Aurovitas during pregnancy is safe. Entecavir Aurovitas should not be taken during pregnancy unless it is specially recommended by your doctor.
It is important that women of childbearing age using Entecavir Aurovitas use effective contraception to avoid becoming pregnant.
Do not breastfeed while taking Entecavir Aurovitas. If you are breastfeeding, inform your doctor. It is not known whether entecavir, the active substance of Entecavir Aurovitas, passes into human breast milk.

Driving and using machines

Dizziness, fatigue, and drowsiness are common side effects that can affect your ability to drive and use machines. If you are unsure, consult your doctor.
Entecavir Aurovitas contains lactose.If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Entecavir Aurovitas

Not all patients need to take the same dose of Entecavir Aurovitas.

Entecavir Aurovitas.

This medicine should always be taken exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
The recommended dose for adultsis 0.5 mg or 1 mg once daily (orally).

The dose depends on:

• previous treatment of HBV infection and the medicines used;
• the presence of kidney function disorders; in this case, your doctor may prescribe a lower dose or recommend taking the medicine less frequently than once daily;
• the patient's liver condition.

Entecavir Aurovitas 0.5 mg:

For children and adolescents(from 2 to less than 18 years of age), the doctor will determine the appropriate dose based on the child's body weight. Children with a body weight of at least 32.6 kg can take a 0.5 mg tablet or entecavir oral solution. For patients with a body weight from 10 kg to 32.5 kg, entecavir oral solution is recommended. All doses are taken once daily (orally). There are no recommendations for Entecavir Aurovitas in children under 2 years of age or weighing less than 10 kg.
Your doctor will determine the appropriate dose based on the child's body weight.

Entecavir Aurovitas 1 mg:

For children and adolescents (from 2 to less than 18 years of age), 0.5 mg Entecavir Aurovitas tablets or entecavir oral solution are available.
Your doctor will determine the appropriate dose based on the child's body weight.
It is the doctor's responsibility to recommend the correct dose. You should always take the dose recommended by your doctor to ensure the full effectiveness of the medicine and to limit the development of resistance to treatment. Entecavir Aurovitas should be taken for as long as your doctor recommends. Your doctor will inform you about the end of treatment.
Some patients may need to take Entecavir Aurovitas on an empty stomach (see Entecavir Aurovitas with food and drink in section 2). If your doctor recommends taking Entecavir Aurovitas on an empty stomach, this means taking the medicine at least 2 hours after a meal and at least 2 hours before the next meal.

Taking more than the recommended dose of Entecavir Aurovitas

Contact your doctor immediately.

Missing a dose of Entecavir Aurovitas

It is important not to miss any dose. If you miss a dose of Entecavir Aurovitas, take it as soon as possible, and then take the next dose at the usual time. If it is almost time for the next dose, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Do not stop taking Entecavir Aurovitas without consulting your doctor

After stopping Entecavir Aurovitas, some people may experience severe hepatitis symptoms. Inform your doctor immediately about any changes in symptoms after stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Entecavir Aurovitas can cause side effects, although not everybody gets them.
Patient groups treated with Entecavir Aurovitas have reported the following side effects:

Adults:

• common (at least 1 in 100 patients): headache, insomnia, fatigue (very strong exhaustion), dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia (indigestion), and increased liver enzyme activity in the blood;
• uncommon (at least 1 in 1,000 patients): rash or hair loss;
• rare (at least 1 in 10,000 patients): severe allergic reactions.

Children and adolescents

Side effects in children and adolescents are similar to those in adults and are described above, with the following difference:
Very common (at least 1 in 10 patients): low neutrophil count (a type of white blood cell important in fighting infections).
If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entecavir Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton, blister, and bottle after: EXP. The expiry date refers to the last day of that month.
Blisters:Store in a temperature below 30°C.
Bottles:No special storage precautions.

6. Contents of the pack and other information

What Entecavir Aurovitas contains

The active substance is entecavir.
Each film-coated tablet contains 0.5 mg of entecavir (as entecavir monohydrate).
Each film-coated tablet contains 1 mg of entecavir (as entecavir monohydrate).
The other ingredients are:
Lactose monohydrate, microcrystalline cellulose 101, microcrystalline cellulose 102, crospovidone (type A), magnesium stearate.
Tablet coating:Hypromellose 2910 (6cp), macrogol 400, titanium dioxide (E 171).

What Entecavir Aurovitas looks like and contents of the pack

Film-coated tablet.
Entecavir Aurovitas, 0.5 mg, film-coated tablets:
White, triangular (8.4 mm in size), biconvex, film-coated tablets, with "ET" engraved on one side and "0 5" on the other side.
Entecavir Aurovitas, 1 mg, film-coated tablets:
White, round (8.2 mm in diameter), biconvex, film-coated tablets, with "ET" engraved on one side and "1" on the other side.
PVC/PVDC/Aluminum blisters: 30 and 90 film-coated tablets.
HDPE bottles with PP caps: 30, 100, and 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Poland

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Arrow Génériques
26 avenue Tony Garnier
69007 Lyon
France
Generis Farmacêutica, S.A.
Rua João de Deus n.˚ 19, Venda Nova
2700-487 Amadora
Portugal

Date of last revision of the package leaflet: 03/2023